MINT-LISINOPRIL TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
07-10-2008
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Werkstoffen:
LISINOPRIL (LISINOPRIL DIHYDRATE)
Beschikbaar vanaf:
MINT PHARMACEUTICALS INC
ATC-code:
C09AA03
INN (Algemene Internationale Benaming):
LISINOPRIL
Dosering:
20MG
farmaceutische vorm:
TABLET
Samenstelling:
LISINOPRIL (LISINOPRIL DIHYDRATE) 20MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/500
Prescription-type:
Prescription
Therapeutisch gebied:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0121550002; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2012-08-02
Productkenmerken
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PRODUCT MONOGRAPH
PR
MINT-LISINOPRIL
lisinopril tablets
5 mg, 10 mg and 20 mg of lisinopril as lisinopril dihydrate
USP
Angiotensin Converting Enzyme Inhibitor
Manufactured for:
Mint Pharmaceuticals Canada Inc.,
1 First Canadian Place, Suite 5600
100 King Street West
Toronto, Ontario
M5X 1E2
Date of Preparation:
September 29, 2008
Submission Control No: 124991
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_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND
ADMINISTRATION.............................................................................
18
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND
STABILITY.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL
INFORMATION.........................................................................
25
CLINICAL
TRIALS...........................................................................................
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